(27 days)
The Acumed Small Bone Locking Rod System II includes rods and screws, with accessories, for indicated use for fractures and osteotomies of the radius, ulna, and fibula.
The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with cortical screws, which lock it in place.
This 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
Therefore, based on the provided document, there is no information available regarding acceptance criteria, device performance, sample sizes for test sets or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The device's substantial equivalence was determined based on its similarities to predicate devices, without the need for new performance data.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.